Document Control Specialist at Mission Bio
South San Francisco, CA, US

Mission Bio is a high-growth, well-funded Series C company based in South San Francisco, California. Our mission is to enable our customers to eradicate cancer. We do so with our innovative microfluidic system that is the leader in the high throughput single cell, multi-omics space that is used by major cancer centers and pharma / biopharma companies globally to better characterize cancer as well as providing solutions to accelerate therapeutic development, such as the future standard of care in cell and gene therapy.

We are a dynamic and diverse team. We live by the culture of “One Cell One Team One Vision”. We are collaborative, we are driven, and we are curious.

Document Control Specialist

The Document Control Specialist is an enthusiastic, self-motivated person with great communication skills who can support the Quality Management System through implementation and management of the document control system as well as supporting compliance and certification activities.  The Document Control Specialist will demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below.  The candidate will be comfortable in a rapidly evolving Biotech environment implementing and evolving a value-added document control system based on ISO and Good Documentation Practices requirements.

Duties/Responsibilities:

Responsible for ensuring all requisite tasks are completed for successful Document Control system functions:

  • Support the development and implementation of Mission Bio’s Document Control system.
  • Manage the document control system and its continuous improvement.  Create or update corresponding standard operating procedures per ISO regulatory standards and Good Documentation Practices (GDP).
  • Create and implement Document Change Order (DCO) process.  Proactively manage document reviews and approvals per DCO process.
  • Provide first-rate customer service to users who have issues or questions regarding the document control system.
  • Review and verify documentation to ensure they are completed appropriately and meet document control system requirements.
  • Train R&D and Operations personnel on document control system use, requirements and Good Documentation Practices.
  • Provide guidance on document control system use to R&D and Operations personnel to improve and ensure compliance.
  • Create and maintain quality metrics as they relate to the document control system and related activities for analysis and continual improvement.
  • Prepare for and assist in internal and external regulatory audits.
  • Performs other related duties as assigned.

Required Skills:

  • Excellent verbal and written communication skills.
  • Excellent interpersonal and customer service skills.
  • Excellent organizational skills and attention to detail.
  • Excellent time management skills with a proven ability to meet deadlines.
  • Proficient with MS Office Suite: Word, Excel and Powerpoint.

Education and Experience:

  • B.S. degree or equivalent with 5+ years of hands-on experience in the pharmaceutical or biotechnology industry, with knowledge of Document Control systems and ISO/FDA Quality System Requirements for Quality Management Systems.
  • Experience with ZenQMS electronic Quality Management System is a plus.
  • Experience in start-up/fast growth company or similar working environment is a plus.
  • Must be comfortable designing training presentations, training others and leading training sessions.
  • Results and goal oriented with the ability to work independently with minimal guidance.